List of documents required for Ethics committee (EC) submission

There are two types of ethics committees(EC) available in India. These are Institutional ethics committee and Independent ethics committee. You can also see the more details about these two ECs here.  Here we have provided a list of documents required for Institutional ethics committee(IEC) for protocol review. Documents requirement also differ from each institutional ethics committees. It is defined according to their standard operating procedures(SOPs). These mentioned documents should be produced in ‘n’ number of sets. Along with these documents hard copies, soft copies should be copied to a CD (Compact  Disk) for reference.   

Overall required documents are as follows

List of Ethics committee documents

  1. Protocol
  2. Case record form
  3. Informed consent form or site specific informed consent form (English copy along with copies in Vernacular languages)
  4. Patient information sheet ( English copy along with copies in vernacular languages)
  5. Patient diary (English copy along with copies in vernacular languages)
  6. Investigator’s brochure
  7. Proposed methods for patient recruitment (Advertisements, Posters etc.)
  8. Clinical Trial Agreement
  9. Protocol signature page
  10. Investigator’s undertaking
  11. Principle Investigator’s Curriculum vitae
  12. Principle investigator’s medical registration certificate
  13. Principle Investigators No conflict of interest statement
  14. Study Insurance
  15. Letter of Indemnification

After completion of submission process along with processing fee cheque, EC will review the documents.

Note: A few ethics committees will have Scientific research society / scientific review board / scientific committees. They will screen and study the submitted documents then forward the project to Ethics committee.

Related: Types of clinical trials

EC will take final decision. Final decision will be decided by voting of ethics committee members. The decision may be anything. Usually types of responses will be given by an Ethics committee are

  1. Approved
  2. Queries raised
  3. Conditionally approved
  4. Rejected

Approved: It is a positive decision for sponsor or study personal. Letter will be issued with protocol number, version number and date. It includes all the details about attended members and list of documents reviewed. It also contains general rules. Those are like inform the progress of study/ Serious adverse events should be informed/ follow the ICMR/ ICH GCP/ Schedule Y guidelines/ study should be registered with CTRI etc. 

Queries raised: In this scenario, EC may raise the queries regarding the study from any point of view (patient safety/ study protocol etc.).

For eg.

1. Explain why ‘n’ numbers of blood tests will be done in short period of time.

2. Explain the rationality for studying the combination of these x and y drugs. Etc.

Receiving queries from the Ethics committee, sponsor need to respond with proper explanation. Required supported documents should be produced in front of EC in the next scheduled meeting with amendment fee.   

Conditional approval: In this case, Ethics committee is okay with the study procedure. EC may instruct that after fulfilling the particular requirement only, this approval is valid.

Rejected: If EC not at all satisfied with the study protocol including unethical procedures. EC may reject the study. Rejection letter will be issued with reasons..

Difference between Phase 3a vs 3b trials: Clinical trials

Phase 3a vs 3b trials:

Here clinical trials phase 3a vs 3b explained here. Phase 3 trials are therapeutic confirmatory trials conduced in 1000-3000 patient population. After getting promising data from the Phase 2 clinical trials. Main objective of the Phase 3 trials are proving or confirming the clinical efficacy with no unacceptable safety concerns. Phase 3 trials have two sub-phases that is phase 3a and phase 3b trials.

Phase 3a trials:

With the efficacy and safety data obtained from the phase 2 trials, phase 3a trials are initiated. Studies are conducted in this phase that supports the initial claims of the sponsor to regulatory authorities. Most of the phase 3 studies are conduced in phase 3a trials like non-inferiority trials, long term safety studies and local registration studies etc.

Most of the studies producing the information supporting the patient information leaflet (PIL) / label along with post marketing commitments. Some studies may also conducted in special population depend upon the drug/disease nature.  

Most of the times drug candidate compared with an active comparator. If there is a lack of standard treatment for target disease, drug candidate compared with the placebo. This phase done before the getting the first indication approval.

Related: phase 2a and Phase 2b clinical trial differences

phase 3a

Phase 3b trials:

This phase starts after getting first approved indication from regulatory authority and before getting the marketing approval/ launch of the drug. While submitting the initial application to the regulatory authority, this phase studies still will go on.

These are additional studies which gather additional information like long term safety and drug effect on quality of life etc.  The intention of these studies is to produce the data supporting the publications and marketing claims. Regulatory approval authorities may rely on these phase 3b studies results before taking a decision on marketing approval of the drug even though the results are not intended for regulatory submissions.

Related: Diabetic drug classification mnemonics

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